Greenberg Jonathan, Levey Nadine S, Becker Molly, Yeh Gloria Y, Giacino Joseph T, Iverson Grant, Silverberg Noah D, Parker Robert A, Vranceanu Ana-Maria
Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Department of Psychiatry, Boston, Massachusetts.
Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.
Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5.
To assess the feasibility of the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program aiming to prevent persistent concussion symptoms among young adults with anxiety, and an active control (Health Enhancement after Concussion [HE-C]). We also tested preliminary improvements in outcome measures and putative mechanistic targets.
Single-blind, 2-arm, randomized controlled trial (RCT).
Academic medical center in the US Northeast.
Fifty young adults (aged 18-35 years) with a recent concussion (3-10 weeks prior) and anxiety (≥5 on the Generalized Anxiety Disorder-7 [GAD-7] questionnaire).
Both interventions consisted of four 45-minute 1:1 sessions with a clinician over Zoom. TOR-C (n=25) taught mind-body, cognitive-behavioral, and return-to-activity skills. HE-C (n=25) taught health education (eg, sleep, nutrition) without skills.
Primary: feasibility outcomes (eg, recruitment, credibility, expectancy, acceptability, safety, feasibility of assessments, fidelity, satisfaction, and TOR-C homework adherence) with a-priori-set benchmarks. Secondary: intervention outcomes were concussion symptoms (Post-Concussion Symptom Scale), physical function (World Health Organization Disability Assessment Scale), anxiety (GAD-7/anxiety subscale of the Hospital Anxiety and Depression Scale), depression (depression subscale of the Hospital Anxiety and Depression Scale) and pain (Numerical Rating Scale). TOR-C mechanistic targets were pain catastrophizing (Pain Catastrophizing Scale), mindfulness (Cognitive and Affective Mindfulness Scale-Revised), fear avoidance (Fear Avoidance Behavior after Traumatic Brain Injury), limiting behavior and all-or-nothing behavior (Behavioral Response to Illness Questionnaire).
Both interventions met all feasibility benchmarks and were associated with significant improvements in outcomes (concussion symptoms, physical function, anxiety, depression, and pain; d=0.44-1.21) and TOR-C mechanistic targets (pain catastrophizing, mindfulness, fear-avoidance, and limiting behavior; Cohen's d=0.41-1.24). Improvements in all-or-nothing behavior were only significant in TOR-C (d=0.52). Improvements in all mechanistic targets except all-or-nothing behavior after TOR-C were significantly associated with improvements in at least one outcome.
Findings provide strong support for the feasibility of TOR-C and HE-C, and preliminary evidence for improvements in mechanistic targets and outcomes. Findings inform a future fully-powered RCT testing efficacy of TOR-C versus HE-C.
评估脑震荡后最佳恢复工具包（TOR-C）的可行性，这是首个旨在预防伴有焦虑的年轻成年人持续性脑震荡症状的身心项目，以及一个积极对照项目（脑震荡后健康促进项目[HE-C]）。我们还测试了结果指标和假定机制靶点的初步改善情况。
单盲、双臂随机对照试验（RCT）。
美国东北部的学术医疗中心。
50名近期（3至10周前）发生脑震荡且伴有焦虑（在广泛性焦虑障碍-7[GAD-7]问卷上得分≥5）的年轻成年人（年龄18至35岁）。
两种干预措施均包括通过Zoom与临床医生进行四次45分钟的一对一课程。TOR-C组（n = 25）教授身心、认知行为和恢复活动技能。HE-C组（n = 25）教授健康教育（如睡眠、营养）但不教授技能。
主要指标：可行性结果（如招募、可信度、预期、可接受性、安全性、评估的可行性、保真度、满意度以及TOR-C家庭作业依从性），有预先设定的基准。次要指标：干预结果包括脑震荡症状（脑震荡后症状量表）、身体功能（世界卫生组织残疾评估量表）、焦虑（GAD-7/医院焦虑抑郁量表焦虑子量表）、抑郁（医院焦虑抑郁量表抑郁子量表）和疼痛（数字评定量表）。TOR-C的机制靶点包括疼痛灾难化（疼痛灾难化量表）、正念（修订后的认知与情感正念量表）、恐惧回避（创伤性脑损伤后的恐惧回避行为）、限制行为和全或无行为（疾病行为反应问卷）。
两种干预措施均达到所有可行性基准，并且与结果（脑震荡症状、身体功能、焦虑、抑郁和疼痛；d = 0.44 - 1.21）以及TOR-C机制靶点（疼痛灾难化、正念、恐惧回避和限制行为；科恩d值 = 0.41 - 1.24）的显著改善相关。全或无行为的改善仅在TOR-C组中显著（d = 0.52）。除TOR-C后的全或无行为外，所有机制靶点的改善均与至少一项结果的改善显著相关。
研究结果为TOR-C和HE-C的可行性提供了有力支持，并为机制靶点和结果的改善提供了初步证据。研究结果为未来一项全面测试TOR-C与HE-C疗效的RCT提供了信息。
